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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer patient examination glove
510(k) Number K223752
Device Name Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
Applicant
Central Medicare Sdn. Bhd.
PT 2609-2620, Batu 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Applicant Contact Chua Kah Ying
Correspondent
Central Medicare Sdn. Bhd.
PT 2609-2620, Batu 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Correspondent Contact Chua Kah Ying
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received12/15/2022
Decision Date 07/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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